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| ID | Type | Description | Link |
|---|---|---|---|
| Ethics ID 22549 | Other Identifier | Conjoint Health Research Ethics Board |
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| Name | Class |
|---|---|
| Alberta Centre for Child, Family & Community Research | OTHER |
| Alberta Health Services, Calgary | OTHER |
| Mount Royal University | OTHER |
| SickKids Foundation |
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The purpose of this project is to explore the potential value and practicality of an innovative depression intervention for young people. More specifically, the objectives of this project are:
to pilot the Internet-based Spirituality Program with depressed young people (age 13-24) in Calgary by:
to gather feedback from depressed young people, their families and referral sources in the community (schools, family physicians, mental health outpatient services) on the perceived value of the program and on ways to eventually make it available as a community resource for others dealing with depression.
Depression in adolescents and young adults is a prevalent illness in Canada and presents a high burden for those affected and their families. In Canada, depressive disorders are on the rise and their onset is occurring earlier in life. There is a growing body of evidence suggesting that spiritual wellness may play a role in depression management and recovery. Considering the limitations of available treatments for depression and the significant burden of the disease there is a need for new treatment options that are safe, effective, affordable and acceptable to young people. Our previous research gives strong support to the idea of using a spiritually based intervention for depression. To our knowledge, no research has been conducted on using spirituality as a self-study intervention in the management of depression in young adults. Over the last two years our team has created a spirituality-based intervention program for adolescent depression. The program could present an innovative and low cost treatment option for young patients with major depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | Arm where participants began the LEAP Project intervention upon recruitment for an 8 week period. |
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| Waitlist Arm | Active Comparator | Arm where participants received the LEAP Project intervention after an 8 week wait period. At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEAP Project | Other | In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles. |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Depression Rating Scale Revised (CDRS-R) | Measure of depression severity in individuals 13 to 18 years of age. CDRS-R total raw scores includes the sum of 17 items, each item's scoring range is from 1 (no difficulties) to 5 (severe clinically significant difficulties) or 1 (no difficulties) to 7 (severe clinically significant difficulties), with a total possible raw score ranging from 17 to 113. To meet eligibility requirements, participants required a total raw score of 40 to 70. | At 8 week intervals over a 24 week period |
| Hamilton Depression Rating Scale (HAMD) | Measure of depression severity in individuals 19 to 24 years of age. HAMD total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression. To meet eligibility requirements, participants required a total score of 12-24. | At 8 week intervals over a 24 week period |
| Measure | Description | Time Frame |
|---|---|---|
| Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2) | Measure of self-concept in 13 to 18 year olds. The scale can be completed in 10-15 minutes and includes 60 items covering six subscales: physical appearance and attributes, intellectual and school status, happiness and satisfaction, freedom from anxiety, behavioural adjustment and popularity. | At 8 week intervals over a 24 week period |
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Inclusion Criteria:
Exclusion Criteria:
In order to avoid confounding through a change in the use of mood altering substances or therapies and through underlying medical conditions, patients will be excluded for any of the following reasons:
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| Name | Affiliation | Role |
|---|---|---|
| John Toews, MD, FRCPC | Canadian Institute of Natural and Integrative Medicine | Principal Investigator |
| Badri Rickhi, MB MD FRCPC | Canadian Institute of Natural and Integrative Medicine | Principal Investigator |
| Jordan Cohen, MD, FRCPC | University of Calgary | Principal Investigator |
| Dawne Clark, PhD | Mount Royal College | Principal Investigator |
| John Griffith, BA MDiv | Spiritual Directions | Principal Investigator |
| Hude Quan, PhD | University of Calgary | Principal Investigator |
| Janet Chafe, MSW, RSW | Alberta Health services | Principal Investigator |
| Sabine Moritz, Bsc MSc | Alberta Health services | Principal Investigator |
| Patti Paccagnan, RN, BN, ACC | Canadian Institute of Natural and Integrative Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Institute of Natural and Integrative Medicine (CINIM) | Calgary | Alberta | T2M 3T1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26702639 | Derived | Rickhi B, Kania-Richmond A, Moritz S, Cohen J, Paccagnan P, Dennis C, Liu M, Malhotra S, Steele P, Toews J. Evaluation of a spirituality informed e-mental health tool as an intervention for major depressive disorder in adolescents and young adults - a randomized controlled pilot trial. BMC Complement Altern Med. 2015 Dec 24;15:450. doi: 10.1186/s12906-015-0968-x. |
| Label | URL |
|---|---|
| Canadian Institute of Natural and Integrative Medicine (CINIM) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Arm, Younger Subgroup | Arm where younger participants (13 to 18 years of age) began the LEAP Project intervention upon recruitment for an 8 week period. LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles. |
| FG001 | Study Arm, Older Subgroup | Arm where older participants (19 to 24 years of age) began the LEAP Project intervention upon recruitment for an 8 week period. LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles. |
| FG002 | Waitlist Arm, Younger Subgroup | Arm where younger participants (13-18 years of age) received the LEAP Project intervention after an 8 week wait period. At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed). LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles. |
| FG003 | Waitlist Arm, Older Subgroup | Arm where older participants (19 to 24 years of age) received the LEAP Project intervention after an 8 week wait period. At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed). LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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For study arm, older subgroup - the sample size indicated is 15 instead of 16 as the one participant dropped out after baseline. As no other data was collected for this participant, the decision of the team was to exclude them from the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Arm, Younger Subgroup | Subgroup of participants 13-18 years of age randomized into the study arm. |
| BG001 | Study Arm, Older Subgroup | Subgroup of participants 19-24 years of age randomized into the study arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Children's Depression Rating Scale Revised (CDRS-R) | Measure of depression severity in individuals 13 to 18 years of age. CDRS-R total raw scores includes the sum of 17 items, each item's scoring range is from 1 (no difficulties) to 5 (severe clinically significant difficulties) or 1 (no difficulties) to 7 (severe clinically significant difficulties), with a total possible raw score ranging from 17 to 113. To meet eligibility requirements, participants required a total raw score of 40 to 70. | Posted | Mean | Standard Error | units on a scale | At 8 week intervals over a 24 week period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Arm, Younger Subgroup | Participants 13-18 years of age randomized into the study group |
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Limitations Inconsistent followup by all study participants Overall generalizability is limited due to a predominantly female sample Self-selection of participants with an open attitude to spirituality No comparison to placebo or active treatment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Toews | Canadian Institute of Natural and Integrative Medicine | 4032200022 | 111 | j.toews@cinim.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| OTHER |
| University of Calgary | OTHER |
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|
| Six Factor Self-Concept Scale | Measure of self concept in 19 to 24 year olds. The Six-Factor Self-Concept Scale is a multidimensional measure of adult self-concept that was designed to have broad applicability across life settings, roles, and activities. The scale consist of 115 items and assess six factors including likability, morality, task accomplishment, giftedness, power and vulnerability. | At 8 week intervals over a 24 week period |
| Profile of Mood States (POMS) | Measure of psychological well-being in 19 to 24 year olds. The POMS has the format of an adjective check list and consists of 65 items. It provides a total score of mood disturbance and six factor based subscale scores. | At 8 week intervals over a 24 week period |
| Spiritual Well-Being Scale (SWBS) | Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used. | At 8 week intervals over a 24 week period |
| Spiritual Involvement and Belief Scale (SIBS) | Measure of spiritual well-being in 19 to 24 year olds. The instrument is self-administered and contains 26 items in a Likert-type format. | At 8 week intervals over a 24 week period |
| The LEAP Project | View source |
| BG002 | Waitlist Arm, Younger Subgroup | Subgroup of participants 13-18 years of age randomized into the waitlist arm. |
| BG003 | Waitlist Arm, Older Subgroup | Subgroup of participants 19-24 years of age randomized into the waitlist arm. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Use of other treatments during intervention phase | Number | participants |
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| Education | Number | participants |
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| Religions denomination indicated | Number | participants |
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| Work situation | Number | participants |
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| Living situation | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Primary | Hamilton Depression Rating Scale (HAMD) | Measure of depression severity in individuals 19 to 24 years of age. HAMD total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression. To meet eligibility requirements, participants required a total score of 12-24. | Posted | Mean | Standard Error | units on a scale | At 8 week intervals over a 24 week period |
|
|
|
| Secondary | Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2) | Measure of self-concept in 13 to 18 year olds. The scale can be completed in 10-15 minutes and includes 60 items covering six subscales: physical appearance and attributes, intellectual and school status, happiness and satisfaction, freedom from anxiety, behavioural adjustment and popularity. | Not Posted | At 8 week intervals over a 24 week period |
| Secondary | Six Factor Self-Concept Scale | Measure of self concept in 19 to 24 year olds. The Six-Factor Self-Concept Scale is a multidimensional measure of adult self-concept that was designed to have broad applicability across life settings, roles, and activities. The scale consist of 115 items and assess six factors including likability, morality, task accomplishment, giftedness, power and vulnerability. | Not Posted | At 8 week intervals over a 24 week period |
| Secondary | Profile of Mood States (POMS) | Measure of psychological well-being in 19 to 24 year olds. The POMS has the format of an adjective check list and consists of 65 items. It provides a total score of mood disturbance and six factor based subscale scores. | Not Posted | At 8 week intervals over a 24 week period |
| Secondary | Spiritual Well-Being Scale (SWBS) | Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used. | Not Posted | At 8 week intervals over a 24 week period |
| Secondary | Spiritual Involvement and Belief Scale (SIBS) | Measure of spiritual well-being in 19 to 24 year olds. The instrument is self-administered and contains 26 items in a Likert-type format. | Not Posted | At 8 week intervals over a 24 week period |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Study Arm, Older Subgroup | Participants 19-24 years of age randomized into the study group | 0 | 15 | 0 | 15 |
| EG002 | Waitlist Arm, Younger Subgroup | Participants 13-18 years of age randomized into the waitlist group | 0 | 13 | 0 | 13 |
| EG003 | Waitlist Arm, Older Subgroup | Participants 19-24 years of age randomized into the wait list group | 0 | 16 | 0 | 16 |
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| Title | Measurements |
|---|---|
|
| Waitlist Arm - Week 8 (n=16) |
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| Study Arm - Week 16 (n=15) |
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| Waitlist Arm - Week 16 (n=16) |
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| Study Arm - Week 24 (n=15) |
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| Waitlist Arm - Week 24 (n=14) |
|